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510(k) K012588

OXOID PYLORI TEST KIT, MODEL DR0130M by Oxoid , Ltd. — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2001
Date Received
August 10, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Helicobacter Pylori
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

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  • K042157 — DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (September 14, 2004)
  • K011710 — OXOID PBP2 1 LATEX AGGLUTINATION TEST (April 2, 2002)
  • K010536 — MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (April 24, 2001)
  • K010537 — LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (April 24, 2001)
  • K000930 — GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (May 22, 2000)
  • K000928 — QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (May 15, 2000)
  • K993401 — DRYSPOT E.COLI 0157 KIT (February 28, 2000)
  • K984513 — TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (April 2, 1999)

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  • K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (July 22, 2016)
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